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Trial record 23 of 397 for:    CLARITHROMYCIN

Clarithromycin as Adjuvant to Periodontal Debridement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02829983
Recruitment Status : Completed
First Posted : July 12, 2016
Results First Posted : October 17, 2017
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Aggressive Periodontitis
Interventions Drug: Clarithromycin
Drug: Placebo
Other: One-stage full-mouth ultrasonic debridement (FMUD)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clarithromycin Group Placebo Group
Hide Arm/Group Description

20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.

Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Placebo: Use of placebo tablets twice a day for 3 days.

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Clarithromycin Group Placebo Group Total
Hide Arm/Group Description

20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.

Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Placebo: Use of placebo tablets twice a day for 3 days.

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
31.4  (3.7) 31.25  (4.6) 31.32  (0.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
19
  95.0%
19
  95.0%
38
  95.0%
Male
1
   5.0%
1
   5.0%
2
   5.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Brazil Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
Probing depht  
Mean (Standard Deviation)
Unit of measure:  Milimeter
Number Analyzed 20 participants 20 participants 40 participants
3.34  (0.56) 3.53  (0.6) 3.43  (0.13)
clinical attachment level  
Mean (Standard Deviation)
Unit of measure:  Milimeter
Number Analyzed 20 participants 20 participants 40 participants
3.48  (0.66) 3.63  (0.7) 3.55  (0.1)
bleeding on probing  
Mean (Standard Deviation)
Unit of measure:  Percentage of sites
Number Analyzed 20 participants 20 participants 40 participants
53  (19) 54  (30) 53.5  (0.7)
gingival recession  
Mean (Standard Deviation)
Unit of measure:  Milimeter
Number Analyzed 20 participants 20 participants 40 participants
0.14  (0.16) 0.1  (0.12) 0.12  (0.028)
plaque index   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of sites
Number Analyzed 20 participants 20 participants 40 participants
59  (23) 62  (25) 60.5  (2.12)
[1]
Measure Description: Plaque index is the relation between the sites with deposits of plaque and the sites of full mouth divided for 100.
1.Primary Outcome
Title Clinical Attachment Level
Hide Description Distance from bottom of pocket to the cement-enamel junction (CEJ).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clarithromycin Group Placebo Group
Hide Arm/Group Description:

20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.

Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Placebo: Use of placebo tablets twice a day for 3 days.

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: milimeter
2.71  (0.35) 3.03  (0.55)
2.Secondary Outcome
Title Probing Depth
Hide Description Distance from the bottom of sulcus/pocket to gingival margin
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clarithromycin Group Placebo Group
Hide Arm/Group Description:

20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.

Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Placebo: Use of placebo tablets twice a day for 3 days.

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: milimeter
2.53  (0.3) 2.86  (0.52)
Time Frame 1 week after periodontal treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clarithromycin Group Placebo Group
Hide Arm/Group Description

20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.

Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Placebo: Use of placebo tablets twice a day for 3 days.

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.

All-Cause Mortality
Clarithromycin Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clarithromycin Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clarithromycin Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      0/20 (0.00%)    
Gastrointestinal disorders     
gastrointestinal discomfort   2/20 (10.00%)  2 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mauro Pedrine Santamaria
Organization: Universidade Estadual Paulista Júlio de Mesquita Filho
Phone: 3947-9033
EMail: mauro.santamaria@ict.unesp.br
Layout table for additonal information
Responsible Party: Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02829983     History of Changes
Other Study ID Numbers: NMRBA
First Submitted: July 8, 2016
First Posted: July 12, 2016
Results First Submitted: May 9, 2017
Results First Posted: October 17, 2017
Last Update Posted: November 21, 2017